New York Governor Kathy Hochul released a proposed set of cybersecurity regulations that require hospitals to establish new policies and procedures to protect themselves from ever-intensifying cyber threats. The state also put aside $500 million in funding to help hospitals upgrade their technology systems to comply with these new rules.
The gene therapy programs of Lexeo Therapeutics span rare forms of cardiomyopathy and certain types of Alzheimer’s disease. But Lexeo’s IPO comes as a rival gene therapy developer sues the biotech, claiming its work employs stolen trade secrets.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A month after an FDA advisory committee voted against recommending approval of BrainStorm Cell Therapeutics’ stem cell therapy for ALS, the company is preparing to try again with a new Phase 3 study. To help pay for it, the biotech is restructuring and laying off 30% of its staff.
NurOwn, BrainStorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.
Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.
Digital therapeutics developer Click Therapeutics is partnering with Indivior to develop a mobile app for substance use disorder. Indivior is now Click’s third development partner, following deals with Boehringer Ingelheim and Otsuka Pharmaceutical.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
GSK claims that Pfizer’s FDA-approved vaccine for respiratory syncytial virus infringes on four patents protecting its own approved vaccine, Arexvy. The patent suit comes with the RSV season approaching.
TG Therapeutics’ multiple sclerosis drug Briumvi will be commercialized in Europe by Neuraxpharm. The Germany-based company paid $140 million up front for certain rights to the drug, which received European Commission approval in June.
Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.
Marstacimab, a Pfizer drug for both hemophilia A and B, met the main goal of a Phase 3 study and the company now plans to discuss the data with regulators. The Pfizer drug could beat to the market a Novo Nordisk drug that addresses the same novel target.
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Enzo BioChem’s sale of its clinical lab business to Labcorp is the culmination of a monthslong strategic review. Meanwhile, diagnostics and lab testing giant Labcorp is in the middle of its own corporate shakeup as it readies its clinical trials business for a spinoff as a standalone, publicly traded company.
Royalty Pharma’s milestone payment from the approval of Pfizer migraine drug Zavzpret stems from financing deals struck with the therapy's previous developer, Biohaven Pharmaceuticals. Royalty Pharma is also in line to receive royalty payments going beyond the next decade.
Pfizer is no stranger to antibody drug conjugate cancer therapies, but it hasn’t been commercially successful with them. The pharma giant’s agreement to acquire Seagen for $43 billion will thrust it to the forefront of the ADC drug class, which has become a hot space for research and regulatory activity in recent years.
Orserdu, a drug from Menarini Group subsidiary Stemline Therapeutics, is now approved for treating breast cancers that carry the ESR1 mutation. The drug is the first approved oral therapy from a class of therapies called selective estrogen receptor degraders (SERDs).
BrainStorm Cell Therapeutics’ stem cell therapy for amyotrophic lateral sclerosis received an FDA refuse-to-file letter, correspondence that informs a company its application seeking approval is incomplete. The notice means BrainStorm might need to run another clinical trial.